Trial Inventory & Recruitment: A Coordinator's Perspective

Mickella Knapp is a Research Coordinator focused on trial innovations that improve efficiency and patient outcomes. Today she shares her perspective on lab kit supply and how it impact a site’s enrollment and recruitment efforts.

Subject recruitment and retention is unquestionably one of the most important aspects of conducting a clinical research trial.

After all, without study subjects there can be no study because, as it turns out, you need subjects to study! Over the years there has been a great deal of discussion and focus around ways to improve subject recruitment and retention, so much so that entire teams are dedicated solely to this process.

From the site perspective, we are often tasked with getting creative in our approaches to find subjects and encourage their continued participation through avenues like physician referrals and frequent contacts during a study, respectively. But how often have we, as an industry, taken a step back and looked at operational barriers that have a negative impact on our ability to recruit and retain subjects?

Let’s take a look into what this really means and consider some points that may support this statistic.

Preparing for Patient Visits

Although we wish things were different, I think it’s safe to say that most coordinators can’t and don’t prepare for study visits weeks ahead of schedule. So realizing you are missing a lab kit a day or two before a patient visit can cause problems like out of window visits or protocol deviations for missing expected labs. These things often require explanations around the what’s, why’s, and how’s, of what happened and that extra work is just that: extra work! In return, taking the time to prepare an explanation, notify the right people, and take steps to prevent a recurrence take time away from recruitment and retention efforts.

Staying on top of your site's clinical trial inventory (and ahead of patient visits) is a constant site challenge.

For example, in order to put a subject through enrollment site staff must ensure they have the proper study supplies, including study drugs, lab kits, specimen shippers, etc. When those necessary supplies aren’t in place significant delays in screening and enrollment visits can take place (especially because these visits almost always require central labs!). And what happens if a visit delay isn’t an option? Chances are, that subject is now considered a screen fail and is no longer eligible to participate. All because the site’s lab inventory wasn’t adequate!

Managing Oversupply

The reverse side of not having enough is having too much. If a study site has several clinical trials taking place at one time they'll need enough clinical trial inventory to support all of their upcoming patient visits for all of their clinical trials. Finding a place to store everything (and keeping organized) is often times a huge nightmare for sites. If a coordinator doesn’t have support at their site to help with supply management it can become a burden big enough to trump subject recruitment and retention.

These are just a couple of examples of how poor supply management can impact subject recruitment and retention. A couple of other points to consider are consistent issues with a vendor perhaps sending the wrong thing, offering a difficult to navigate ordering process, or having an excessive delay in delivery times.

Would you want to spend a considerable amount of time working through these issues on a trial with high subject recruitment? How likely do you think a participant is to continue returning to a site for study visits if there has been a history of missed assessments or last minute rescheduling? Sounds awfully inconvenient, doesn’t it?

The point here is simple: there are already enough moving parts to coordinate at the research site level! Managing your study drugs, lab kits, shippers, bulk supplies, and equipment should not be a burden, especially to the extent that they take away from subject focus. Clinical research participants are the most important aspect of a study so let’s focus on ways to increase our attention to them and minimize the amount of effort required to manage all the things that power a clinical trial.